Principal Regulatory Affairs Specialist

Lumicity

📍
Posted May 20, 2026
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Job Overview

Position

Principal Regulatory Affairs Specialist

Company

Lumicity

Location

Work Type

On-site

Job ID

li-4416191445

Job Description

Key Duties

  • Lead regulatory strategy for pharma and drug-device combination products from development through post-market stages

  • Prepare and review INDs, NDAs, supplements, and other regulatory filings

  • Act as main liaison with FDA CDER, supporting agency meetings and regulatory communications

  • Support global submissions, assess regulatory impact of changes, and mentor junior RA team members

Qualifications & Experience

  • 5+ years of Regulatory Affairs experience within pharma, biotech, or combination products

  • Strong background with FDA CDER submissions including INDs, NDAs, and supplements

  • Proven success managing FDA interactions and executing regulatory strategies

  • Experience with drug-device combination products and related FDA requirements is required
✦

Interview Prep

AI-powered insights to help you prepare

Key Skills

Required:
Preferred:

Practice Questions

💡Technical Questions (3)
  • 1.How do you approach developing a regulatory strategy for a drug-device combination product, and what are the key FDA CDER requirements you prioritize during the development phase?
  • 2.Can you walk me through your process for preparing and reviewing an NDA, specifically focusing on how you ensure completeness and address potential FDA concerns before submission?
  • 3.When assessing the regulatory impact of a post-market change to a drug-device combination product, how do you determine whether a supplement is required versus a standard annual report submission?
🎯Behavioral Questions (3)
  • 1.Tell me about a time you had to lead a regulatory strategy for a complex product that faced significant pushback or skepticism from the FDA during a meeting.
  • 2.Describe a situation where you had to mentor a junior regulatory affairs professional who was struggling with a complex filing or understanding FDA requirements.
  • 3.Give me an example of when you had to assess the regulatory impact of an unexpected manufacturing change for a marketed product and communicate the necessary steps to senior leadership.
🧩Situational Questions (2)
  • 1.You are the lead regulatory liaison for an upcoming Pre-NDA meeting with FDA CDER regarding a novel drug-device combination product. One week before the meeting, your clinical team discovers a minor discrepancy in the device's usability data. How do you handle this?
  • 2.A cross-functional team wants to make a significant label change for a global product that is currently under FDA review via a supplement, but they are pressuring you to submit it immediately without fully assessing the global regulatory impact. How do you respond?

Resume Keywords

Make sure these keywords appear on your resume

Regulatory StrategyDrug-Device CombinationINDNDAFDA CDERRegulatory FilingsPost-MarketSupplementsGlobal SubmissionsMentoringRegulatory Impact AssessmenteCTD

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